CN106413608B

CN106413608B - Sternal closure cerclage, plate implant and instrument

Info

Publication number: CN106413608B
Application number: CN201580023355.5A
Authority: CN
Inventors: S·R·加西亚; R·N·卢比; B·威尔科克斯; S·锡德韦尔; A·布吕诺; S·辛克; R·黑尔; B·威藤
Original assignee: Zimmer Biomet CMF and Thoracic LLC
Current assignee: Zimmer Biomet CMF and Thoracic LLC
Priority date: 2014-03-14
Filing date: 2015-03-11
Publication date: 2020-08-18
Anticipated expiration: 2035-03-11
Also published as: JP2017507758A; WO2015142588A2; WO2015142588A3; AU2015231821B2; EP3116424A2; CN111772757A; AU2021254673A1; EP3572019A1; AU2015231821A1; CA2942854C; AU2020201496B2; AU2020201496A1; CA2942854A1; CN106413608A; EP3116424B1; JP2019217349A; JP6585071B2

Abstract

A closure system may secure a first bone portion to a second bone portion. The closure system may include a strap, a locking terminal, and a tensioning device. The band may be adapted to encircle the first and second bone portions. The locking terminal may fixedly engage a first portion of the strap and selectively fixedly engage a second portion of the strap. The tensioning device may include a body and a threaded rod. The threaded rod may be received in the body and may engage the band such that movement of the threaded rod relative to the body moves the second portion of the band relative to the first portion of the band.

Description

Sternal closure cerclage, plate implant and instrument

Cross Reference to Related Applications

This application claims the benefit and priority of U.S. patent application No.14/466,485, filed on day 8, month 22, 2014, which claims the benefit of U.S. provisional application No.61/953,216, filed on day 3, month 14, 2014. The entire contents of each of the above applications are incorporated herein by reference.

Technical Field

The present disclosure relates to sternal closure devices and instruments.

Background

This section provides background information related to the present disclosure and is not necessarily prior art.

Surgery is often performed on humans and animals to treat diseases or injuries. Such procedures can result in the surgeon having to repair separated, cut or split bone. In the case of injury, the surgeon needs to immobilize and fix two or more bone portions together to allow the bone to heal over time. For example, treating certain diseases, such as heart disease, often requires a surgeon to cut the patient's sternum to access the patient's heart and perform a surgical procedure on the patient's heart. Once the cardiac surgical procedure is completed, the cut chest can be repaired by immobilizing and joining separate portions of the chest together allowing the chest to heal over time. It is often desirable to apply a compressive force that squeezes the bone portions together to promote healing of the bone.

Disclosure of Invention

This section provides a general summary of the disclosure, and is not a comprehensive disclosure of its full scope or all of its features.

In one form, the present disclosure provides a closure system for securing a first bone portion to a second bone portion. The closure system may include a strap, a locking terminal, and a tensioning device. The band may be adapted to encircle the first and second bony portions. The locking terminal may fixedly engage a first portion of the strap and selectively fixedly engage a second portion of the strap. The tensioning device may include a body and a threaded rod. The threaded rod may be received in the body and may engage the band such that movement of the threaded rod relative to the body moves the second portion of the band relative to the first portion of the band.

In some embodiments, the closure system may further comprise a bracket that engages the strap. The bracket can be fastened to one or both of the bone parts. The band and stent may be implantable in the human body. The first and second bone portions may be first and second portions of a sternum.

In some embodiments, the tensioning device includes a sleeve slidably receiving the body.

In some embodiments, the tensioning device includes a resiliently flexible ferrule received into the sleeve and receiving a portion of the body.

In some embodiments, the ferrule includes a first axial end that engages an annular groove in the body and a second axial end that removably engages the locking terminal.

In some embodiments, the sleeve is axially movable relative to the body and the ferrule between a first position that limits radial flexure of the ferrule and a second position that allows the ferrule to flex radially outward relative to the body.

In some embodiments, the tensioning device includes an adjustment member partially received into the body and threadingly engaging the threaded rod, the adjustment member being rotatable relative to the body and axially fixed relative to the body such that rotation of the adjustment member relative to the body causes corresponding axial movement of the threaded rod relative to the body.

In some embodiments, the tensioning device includes an anti-rotation pin extending through the body and engaging the threaded rod to limit relative rotation between the threaded rod and the body while allowing relative axial movement between the threaded rod and the body.

In some embodiments, the tensioning device includes a toggle lock mounted to the threaded rod and movable relative to the threaded rod between an unlocked position allowing movement of the strap through the aperture in the threaded rod and a locked position in which the toggle lock engages the strap and restricts movement of the strap relative to the threaded rod.

In some embodiments, the locking terminal includes a housing and a cam member. The housing may engage the first portion of the strap. The cam member is rotatable relative to the housing and the first portion of the band between an unlocked position allowing the second portion of the band to move through the housing and a locked position in which the cam member engages the second portion of the band to restrict movement of the second portion relative to the housing and the first portion.

In some embodiments, the housing comprises a first housing member and a second housing member. The first portion of the band and the cam member may be disposed between the first housing member and the second housing member.

In some embodiments, the first and second housing members and the first portion of the strap each include apertures that align with one another to allow the second portion of the strap to pass therethrough.

In some embodiments, the housing is a one-piece unitary body.

In some embodiments, in the locked position, the cam member clamps the second portion of the strap against the housing.

In some embodiments, the first portion of the band includes a deflectable tab that allows and limits movement of the cam member from the unlocked position to the locked position.

In some embodiments, the cam member includes a deflectable tab that releasably engages the housing in the locked position to limit movement of the cam member out of the locked position.

In some embodiments, in the locked position, the deflectable tab releasably engages a first aperture (e.g., a hole, groove, notch, or slot) in the housing member to limit movement of the cam member out of the locked position. In the unlocked position, the deflectable tab may releasably engage a second aperture (e.g., a hole, groove, notch, or slot) in the housing to limit movement of the cam member out of the unlocked position.

In some embodiments, the body includes a member secured to an axial end of the body. The member may include an edge defining a central recess that receives the locking terminal. The edge may include a keyway that receives a portion of the cam member such that relative rotation of the body with respect to the locking terminal causes the cam member to rotate from the unlocked position to the locked position.

In some embodiments, the member includes a shear aperture through which the second portion of the strap extends. The wall of the shear aperture may be configured to sever the second portion of the strap in response to rotation of the body relative to the locking terminal.

In some embodiments, the shear aperture is configured such that a wall of the shear aperture only severs the second portion of the band after the body has been rotated at least ninety degrees relative to the locking terminal.

In some embodiments, the shear orifice is a bow-tie shaped orifice.

In another form, the present disclosure provides a tensioning device for tightening a band about a first bone portion and a second bone portion. The tensioning device may include an elongated body, a threaded rod, a sleeve, and a resiliently flexible locking arm. The elongated body may include a central aperture extending axially through the body. The threaded rod may be received in the central aperture of the body and may be adapted to engage the band such that movement of the threaded rod relative to the body moves the second portion of the band relative to the first portion of the band. The sleeve may slidably receive the body. A locking arm may extend from the body and may be configured to releasably secure the tensioning device relative to the strap.

In some embodiments, the locking arm is part of a collar that is received into the sleeve and receives a portion of the body.

In some embodiments, the ferrule includes an axial end that engages an annular groove in the body.

In some embodiments, the sleeve is axially movable relative to the main body and the locking arm between a first position restricting radial flexing of the locking arm and a second position allowing the locking arm to flex radially outward relative to the main body.

In some embodiments, the tensioning device includes an adjustment member partially received in the body and threadingly engaging the threaded rod. The adjustment member may be rotatable relative to the body and may be axially fixed relative to the body such that rotation of the adjustment member relative to the body causes corresponding axial movement of the thread relative to the body.

In some embodiments, the tensioning device includes an anti-rotation pin extending through the body and engaging the screw to limit relative rotation between the screw and the body while allowing relative axial movement between the screw and the body.

In some embodiments, the body includes a shear secured to an axial end of the body, the shear including an edge defining a central recess and a keyway extending through the edge.

In some embodiments, the shear includes a shear aperture extending from the central groove of the shear to the central aperture of the body.

In some embodiments, the shear orifice is a bow-tie shaped orifice.

The tensioning device may be incorporated into a closure system that includes a locking terminal having a first housing member, a second housing member, and a cam member. The first portion of the band and the cam member are disposed between the first housing member and the second housing member.

In some embodiments, the cam member is rotatable relative to the first and second housing members and the first portion of the band between an unlocked position that allows the second portion of the band to move through the apertures of the first and second housing members and the apertures of the first portion and a locked position in which the cam member engages the second portion of the band to restrict the second portion from moving through the apertures of the first and second housing members and the apertures of the first portion.

In some embodiments, in the locked position, the cam member clamps the second portion of the strap against the second housing member.

In some embodiments, the central groove of the shear receives the locking terminal. The key slot of the shear member may receive a portion of the cam member such that relative rotation of the body with respect to the locking terminal causes the cam member to rotate from the unlocked position to the locked position.

In some embodiments, the second portion of the band extends through the shear aperture. The wall of the shear aperture may be configured to sever the second portion of the strap in response to rotation of the body relative to the locking terminal.

In some embodiments, the shear aperture is configured such that a wall of the shear aperture only severs the second portion of the band after the body is rotated at least ninety degrees relative to the locking terminal.

In another form, the present disclosure provides a closure system that can secure a first bone portion to a second bone portion. The closure system may include a bracket, a strap, and a tensioning device. The scaffold may include a first portion adapted to engage a first bone portion and a second portion adapted to engage a second bone portion. The band may engage the scaffold and may be adapted to encircle the first and second bone portions. The tensioning device may include a body and a threaded member. The threaded member may be received into the body and may engage the band such that rotation of the threaded member relative to the body moves the first end of the band relative to the second end of the band.

In some embodiments, the band and stent can be implanted in a human body.

In some embodiments, at least a portion of the tensioning device is implantable within the human body.

In some embodiments, the first and second bone portions are first and second portions of a sternum.

In some embodiments, the threaded member threadingly engages the band.

In some embodiments, the body of the tensioner fixedly engages the first end of the belt.

In some embodiments, the bracket fixedly engages the first end of the strap.

In some embodiments, the band includes a plurality of apertures configured to receive the threads of the threaded member.

In some embodiments, the closure system includes a cam member that is movable relative to the bracket between a first position that allows movement of the band relative to the bracket and a second position that restricts movement of the band relative to the bracket.

In some embodiments, the tensioning device can be removed from the bracket and the strap without releasing the tension of the strap.

In some embodiments, the threaded member includes a threaded shaft including a slot configured to receive the band such that the band winds onto the threaded shaft during rotation of the threaded member relative to the body.

In some embodiments, the body includes a plurality of guide apertures axially aligned with the apertures in the bracket.

In some embodiments, the sleeve is molded around the band and through at least one aperture in the band.

In another form, the present disclosure provides a closure system for securing a first bone portion to a second bone portion. The closure system may include a bracket, a strap, and a tensioning device. The scaffold is adapted to engage at least one of the first bone portions. The band may engage the scaffold and may be adapted to encircle the first and second bone portions. The tensioner may include a base and a tensioning member. The tensioning member may rotatably engage the base and may engage the strap such that rotation of the tensioning member relative to the base tensions the strap relative to the first and second bone portions.

In some embodiments, the band and stent can be implanted in a human body.

In some embodiments, the tensioning member comprises a threaded member.

In some embodiments, the tensioning member threadably engages the belt.

In some embodiments, the tensioning member twists the belt relative to the bracket.

In some embodiments, the first end of the belt is fixed relative to the bracket and the second end of the belt moves relative to the first end of the belt as the tensioning member rotates relative to the body.

In some embodiments, the first and second ends of the band move relative to the bracket as the tensioning member rotates relative to the body.

In some embodiments, the band includes a plurality of apertures configured to receive threads of the tensioning member.

In some embodiments, the tensioner includes a threaded shaft including a slot configured to receive the belt such that the belt wraps onto the threaded shaft during rotation of the tensioner relative to the base.

In some embodiments, the base includes a plurality of guide apertures axially aligned with the apertures in the bracket.

Further areas of applicability will become apparent from the description provided herein. The description and specific examples in the summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.

Drawings

The drawings described herein are for illustrative purposes only of selected embodiments and not all possible implementations, and are not intended to limit the scope of the present disclosure.

FIG. 1 is a partial perspective view of the anterior side of the sternum and ribs of a human body with a closure device attached thereto according to the principles of the present disclosure;

FIG. 2 is a perspective view of the closure device;

FIG. 3 is an exploded perspective view of the closure device;

FIG. 4 is a perspective view depicting a tensioning device of the closure device adjustably engaging a strap of the closure device;

FIG. 5 is a cross-sectional view of the closure device taken along line 5-5 of FIG. 4;

FIG. 6 is a perspective view of the closure device after the end of the strap has been trimmed in accordance with the principles of the present disclosure;

FIG. 7 is a perspective view of the closure device after the ends of the strap have been bent in accordance with the principles of the present disclosure;

FIG. 8 is a perspective view of the closure device and a securing member aligning a plurality of fasteners relative to the closure device;

FIG. 9 is a perspective view of the closure device and fastener of FIG. 8 depicting a screwdriver driving one fastener;

FIG. 10 is a perspective view of the closure device with all fasteners driven through the bracket of the closure device.

FIG. 11 is a perspective view of another configuration of the closure device in a first position according to the principles of the present disclosure;

FIG. 11a is a cut-away perspective view of a belt with a sleeve according to the principles of the present disclosure;

FIG. 12 is an exploded perspective view of the strap, bracket and locking device of the closure device of FIG. 11;

FIG. 13 is an exploded perspective view of the tensioning device of the closure device of FIG. 11;

FIG. 14 is a cross-sectional view of the closure device of FIG. 11;

FIG. 15 is another cross-sectional view of the closure device of FIG. 11;

FIG. 16 is a perspective view of an end of the tensioning device of FIG. 13;

FIG. 17 is a partial plan view of the strap, bracket and locking device of FIG. 12;

FIG. 18 is a partial perspective view of the closure device of FIG. 11;

FIG. 19 is a perspective view of the tensioner in a second position;

FIG. 20 is a perspective view of the tensioner in a third position;

FIG. 21 is a partial perspective view of the tensioner in a fourth position;

FIG. 22 is a partial cross-sectional view of the tensioner in a fourth position;

FIG. 23 is a perspective view of the locking device in a locked position;

FIG. 24 is a cross-sectional view of the locking device in a locked position;

FIG. 25 is a perspective view of another locking device in an unlocked position;

FIG. 26 is another perspective view of the locking device of FIG. 25 in an unlocked position;

FIG. 27 is a perspective view of the locking device of FIG. 25 in a locked position; and

fig. 28 is another perspective view of the locking device of fig. 25 in a locked position.

Corresponding reference characters indicate corresponding parts throughout the several views of the drawings.

Detailed Description

Exemplary embodiments will now be described more fully with reference to the accompanying drawings.

The exemplary embodiments are provided so that this disclosure will be thorough and will fully convey the scope to those skilled in the art. Numerous specific details are set forth such as examples of specific components, devices, and methods to provide a thorough understanding of embodiments of the present disclosure. It will be apparent to those skilled in the art that specific details need not be employed, that example embodiments may be embodied in many different forms and that neither should be construed to limit the scope of the disclosure. In some exemplary embodiments, well-known processes, well-known device structures, and well-known technologies are not described in detail.

The terminology used herein is for the purpose of describing particular example embodiments only and is not intended to be limiting. As used herein, terms that are not modified by a quantitative term or are modified by the term "the" may be intended to include the plural as well, unless the context clearly indicates otherwise. The terms "comprises," "comprising," "including," and "having," are inclusive and therefore specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order discussed or illustrated, unless specifically identified as an order of performance. It should also be understood that additional or alternative steps may be employed.

When an element or layer is referred to as being "on," "engaged with," "connected to," or "coupled with" another element or layer, it can be directly on, engaged, connected or coupled with the other element or layer or intervening elements or layers may be present. In contrast, when an element is referred to as being "directly on," "directly engaged with," "directly connected with," or "directly coupled with" another element or layer, there are no intervening elements or layers present. Other words used to describe the relationship between elements should be interpreted in a similar manner (e.g., "between …" versus "directly between …," "adjacent" versus "directly adjacent," etc.). As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

Although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as "first," "second," and other numerical terms used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.

Spatially relative terms, such as "inner," "outer," "below," "lower," "above," "upper," and the like, may be used herein to describe one element or feature's relationship to another element or feature as illustrated for ease of description. Spatially relative terms may be intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" the other elements or features. Thus, the example term "below" may encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

Referring to fig. 1, a closure system in accordance with the principles of the present disclosure is generally identified by reference numeral 10. The system 10 is depicted as being operatively associated with a sternum 12 of a human body. Sternum 12 as shown has previously undergone a medical procedure known as a median sternotomy. As a result of this surgical procedure, sternum 12 has been cut, allowing the physician access to the tissues and/or organs located within the patient's chest cavity. However, sternum 12 is again approximated such that the previously cut

portions

12a, 12b are now joined together by system 10.

With continued reference to fig. 1-10, the system 10 may include a cerclage or strap 14, a stent 16, and a tensioning device 18. As shown in fig. 2, the needle 20 may be temporarily attached to a first end 22 of the band 14. The needle 20 may be attached to the first end 22 using, for example, a fastener and/or a press-fit or snap-fit. The second end 24 of the belt 14 may be secured to the tensioner 18. The strap 14 may be a flat, elongated, flexible member formed of, for example, a metallic material and/or a polymeric material. In some embodiments, band 14 may comprise a woven material. The strap 14 may include a plurality of parallel slots 26 formed therein. In some embodiments, the sleeve 28 (fig. 2 and 3) may receive a portion of the band 14. In some embodiments, sleeve 28 may be molded onto band 14 or otherwise integrally formed with band 14.

The bracket 16 may be a plate formed from a metal and/or polymer material and may include a body 30 and a plurality of legs 32 extending outwardly from the body 30. The brackets 16 may be relatively flexible such that when the brackets 16 are secured to the sternum 12 (as shown in fig. 1), the brackets 16 are able to conform to the contours of the sternum 12. The body portion 30 may include an opening 34 extending therethrough. In the event that the sternum 12 needs to be reopened after the system 10 is installed, the opening 34 may allow the frame 16 to be easily severed using, for example, a tape cutter or other standard operating room tool. Body portion 30 may also include a plurality of tabs 36 that cooperate to define a channel 38 through which strap 14 is slidably received. Each of the plurality of legs 32 may include one or more apertures 40 extending therethrough. Self-tapping threaded fasteners 42 may extend through the apertures 40 and may threadably engage the sternum 12 to secure the bracket 16 to the sternum 12 (as shown in fig. 1).

The tensioning device 18 may include a receiver 44 and a tensioning screw 46. The receiver 44 may include a body portion 48 and a tab 50. As shown in fig. 5, the body portion 48 may include a recess 52, a first opening 54, and a second opening 56. The first opening 54 and the second opening 56 may be generally adjacent to each other and in communication with the recess 52. The tab 50 may extend outwardly from the main body portion 48 and may fixedly engage the second end 24 of the band 14. The second end 24 may be received within a slot 58 (fig. 5) in the tab 50 and may be secured thereto by, for example, a pin, welding, crimping, and/or one or more fasteners, or any other suitable means.

As shown in fig. 5, the tensioning screw 46 may include a head 60 and a shank 62. The head 60 may include threads 64 and one or more slots 66 capable of receiving the tip of a screwdriver. The head 60 may be received into the recess 52 of the receiver 44 such that the shank 62 extends through the first opening 54 of the receiver 44. As shown in fig. 5, first end 22 of strap 14 may be inserted through second opening 56 and groove 52 of receiver 44. Threads 64 of tension screw 46 may engage slot 26 in strap 14 such that as tension screw 46 rotates relative to receiver 44, strap 14 moves up and down (relative to the frame of reference of fig. 5) relative to receiver 44 based on the direction in which tension screw 46 rotates.

With continued reference to fig. 1-10, a method for attaching the system 10 to the sternum 12 and tensioning the band 14 to again approximate the sternum 12 will be described. With the needle 20 attached to the first end 22 of the strap 14 (as shown in fig. 2), the first end 22 of the strap 14 may wrap around the posterior side of the sternum 12 such that the strap 14 substantially constrains the sternum 12. Once strap 14 is looped around sternum 12, needle 20 may be removed from strap 14 and first end 22 of strap 14 may be inserted up through receptacle 44 (shown in FIG. 5). As shown in fig. 1, the brace 16 may be positioned such that the split separating the two

portions

12a, 12b of the sternum 12 is visible in the opening 34 of the brace 16 (i.e., such that two legs 32 of the brace 14 are aligned with one

portion

12a, 12b of the sternum 12 and the other two legs 32 are aligned with the

other portion

12a, 12b of the sternum 12).

A tensioning device 18 may be used to tighten the strap 14 around the sternum 12 to join the

portions

12a, 12b of the sternum 12 together. As described above, the tensioning screw 46 may be rotated relative to the receiver 44 to move the strap 14 upward (relative to the frame of reference of fig. 5) to tighten the strap 14 about the sternum 12 by a desired amount. Once strap 14 has been tightened to the desired amount, first end 22 of strap 14 may be trimmed (as shown in FIG. 6) and then folded over tab 50 of receptacle 44 (as shown in FIG. 7).

With the straps 14 sufficiently tightened about the sternum 12, the brackets 16 may be secured to the sternum 12 with fasteners 42. That is, the fastener 42 may be inserted through the aperture 40 in the bracket 16 and driven into the sternum 12 with a screwdriver (e.g., a manual or powered screwdriver). As shown in fig. 8 and 9, the securing member 68 may be used to retain the fastener 42 as the fastener 42 is driven through the aperture 40 and into the sternum 12. The fixture 68 may include a plurality of tubes 70 having apertures 72 sized to receive the fasteners 42. The tubes 70 may have the same spacing and relative orientation as the apertures 40 so that the mounts 68 can be aligned relative to the bracket 16 so that the apertures 72 are aligned with the apertures 40 (as shown in fig. 8). With the fastener 68 in this position, a screwdriver 74 (fig. 9) can drive fasteners through the

apertures

72, 40 and into the sternum 12.

While the system 10 is described above as including the brace 16, it will be appreciated that the strap 14 and tensioning device 18 may be used to reapproximate the sternum 12 without the brace 16.

Referring to fig. 11-24, another closure system 7000 that can be used to secure portions of a bone (e.g., sternum 12) to one another is provided. The closure system 7000 may include a strap 7014, a bracket 7016, a locking device or terminal 7017, and a tensioning device 7018. The band 7014, stent 7016, and locking device 7017 may be implantable in the patient. As explained in more detail below, the tensioning device 7018 is operable to tighten the band 7014 around the patient's bone and can be removed from the closure system 7000 prior to completion of the surgical procedure during which the band 7014, stent 7016 and locking device 7017 are implanted. The closure system 7000 can be a fully contained, multi-function device that can access the patient's sternum, tension the band 7014 around the sternum, lock the band 7014 in a tensioned state, and trim away the excess length of the band 7014 without the aid of other instruments. The manufacturer can provide the closure system 7000 to the health care facility and/or the health care professional with the tensioning device 7018 pre-attached to the locking device 7017 (the manufacturer can pre-attach the tensioning device to the strap 7014 and the brace 7016).

The band 7014 may be a flat, elongated, and flexible member formed of, for example, a metallic material and/or a polymeric material. In some embodiments, the band 7014 can comprise a woven material. In some embodiments, the band 7014 can include a sleeve 7015 that covers some or all of the band 7014. For example, as shown in fig. 11a, the sleeve 7015 can be a molded polymer and can be molded onto the band 7014. The sleeve 7015 may be molded through an aperture 7013 in the band 7014 to inhibit or prevent the sleeve 7015 from delaminating or separating from the band 7014 when the band 7014 is slid through the locking device 7017 or locked into place by the locking device 7017. As shown in fig. 11, the needle 7020 may be temporarily attached to the first end 7022 of the band 7014. The needle 7020 may be attached to the first end 7022 using, for example, a fastener and/or a press fit or snap fit.

The second end 7024 of the strap 7014 may be secured to a locking device 7017. As shown in fig. 12, the second end 7024 of the band 7014 may include a generally hook-shaped resiliently flexible tab 7026. The distal end 7028 of the tab 7026 may be inclined or angled relative to the proximal end 7030 of the tab 7026. The tab 7026 partially defines a first orifice 7032. The second end 7024 may also include a second orifice 7034 and a third orifice 7036. The second orifice 7034 can be an elongated, generally rectangular opening sized to allow the first end 7022 of the band 7014 to pass therethrough.

As shown in fig. 12, the stent 7016 may be a plate formed from a metal and/or polymer material and may include a main body portion 7038 and a plurality of legs 7040 extending outwardly from the main body portion 7038. The stent 7016 may be relatively flexible such that the stent 7016 is able to conform to the contours of the sternum 12 when the stent 7016 is secured to the sternum 12. The main portion 7038 may include an opening 7042 extending therethrough. The opening 7042 may allow the stent 7016 to be easily cut using, for example, a strap cutter, or other standard operating room tools if the

portions

12a, 12b of the sternum 12 need to be separated to open the patient's chest after the closure system 7000 is installed. The main body portion 7038 may also include a channel 7044 through which the band 7014 is slidably received. Each of the plurality of legs 7040 may include one or more threaded apertures 7046 extending therethrough. A threaded fastener (not shown) may extend through the aperture 7046 and may threadably engage the sternum 12 to secure the bracket 7016 to the sternum 12. The shape of the body portion 7038, the shape and size of the channel 7044 relative to the band 7014, and the manner in which the stent 7016 is retained by the band 7014 and the locking device 7017 allow the stent 7016 to be substantially adjustable relative to the sternal incision line of the patient's sternum 12 prior to securing the stent 7016 to the sternum 12 with the fasteners.

As shown in fig. 12, the locking device 7017 can include a first housing member 7048, a second housing member 7050, and a cam member 7052. The first housing member 7048 can include a first protrusion 7054, a second protrusion 7056, an elongated orifice 7058, and a pair of resiliently flexible arms 7060. The second housing component 7050 can include a main body 7062 and a pair of arms 7064 that cooperate to form a groove 7066. The main body 7062 may include a first orifice 7068, an elongated second orifice 7070, and a third orifice 7072. The cam member may include a main body 7073 and a tab 7076 extending from the main body. The main body 7073 may include an orifice 7078. As shown in fig. 23, the grooves 7080 can be formed in a portion of the main body 7073 and the tabs 7076.

The arm 7060 of the first housing member 7048 can be snap-fit into engagement with the groove 7074 in the arm 7064 of the second housing member 7050 such that the first housing member 7048 and the second housing member 7050 cooperate to define a cavity 7077 (fig. 23) therebetween in which the cam member 7052 and the second end 7024 of the band 7014 are disposed. The first protrusion 7054 of the first housing member 7048 can extend through the first aperture 7032 of the second end 7024 of the band 7014, through the aperture 7078 in the cam member 7052, and into the first aperture 7068 of the second housing member 7050. As shown in fig. 24, the

elongated apertures

7058, 7034, 7070 can be aligned with one another to enable the first end 7022 of the band 7014 to pass therethrough. The second protrusion 7056 of the first housing member 7048 can be received into the third apertures 7036 of the band 7014 and the third apertures 7072 of the second housing member 7050.

The cam member 7052 is rotatable relative to the first and

second housing members

7048, 7050 and the band 7014 about the longitudinal axis of the first protrusion 7054 between an unlocked position (fig. 17 and 18) and a locked position (fig. 23 and 24). In the unlocked position, the main body 7073 of the cam member 7052 is positioned to allow the strap 7014 to pass freely through the

elongated apertures

7058, 7034, 7070. In the locked position, the main body 7073 of the cam member 7052 clamps the band 7014 against the second housing member 7050 (as shown in fig. 24) to limit or prevent the band 7014 from moving through the

elongated apertures

7058, 7034, 7070. As shown in fig. 24, in the locked position, the cam member 7052 bends the band 7014 into an S-shape, which further limits movement of the band 7014 relative to the locking device 7017. As shown in fig. 23, the distal end 7028 of the tab 7026 of the second end 7024 of the band 7014 limits or prevents rotation of the cam member 7052 from the locked position toward the unlocked position while allowing rotation of the cam member 7052 from the unlocked position to the locked position.

Referring now to fig. 13-15, the tensioning device 7018 may include a main body 7082, a tensioning rod 7084, an adjustment member 7086, a release sleeve 7088, a retaining collar 7090, and a finishing member 7092. The main body 7082 may be a generally cylindrical member that includes a grip portion 7093 and a shaft portion 7095. The unthreaded central aperture 7094 extends completely through the grip portion 7093 and the shaft portion 7095. The grip 7093 may include a pair of flanges 7096 extending radially outward therefrom. An axial end of the grip 7093 may include a groove 7098 in communication with the orifice 7094. A radially extending orifice 7100 can extend through one flange 7096 and communicate with a central orifice 7094. An anti-rotation pin 7102 may be received in the aperture 7100 and may engage the tension bar 7084.

The tensioning rod 7084 may include a threaded shaft 7104 and a head 7106. The threaded shaft 7104 may be movably received into the unthreaded central aperture 7094 of the main body 7082. The end 7103 of the anti-rotation pin 7102 is received into the slot 7105 of the threaded shaft 7104 to prevent the tension rod 7084 from rotating relative to the main body 7082 while still allowing the tension rod 7084 to move axially (in a direction along the longitudinal axis of the shaft 7104) relative to the main body 7082. The tensioning rod 7084 includes a central bore 7108 extending completely through the threaded shaft 7104 and the head 7106. As shown in fig. 14 and 15, the band 7014 can extend through a central aperture 7108 of the tension bar 7084. The head 7106 includes a larger diameter than the threaded shaft 7104 and includes a recess 7110 that communicates with a central aperture 7108.

The toggle lock member 7112 may be rotatably received into the groove 7110. A pin 7114 (fig. 13) may be attached to the head 7106 and rotatably support the toggle lock member 7112 for movement between an unlocked position (shown in phantom in fig. 15) and a locked position (shown in solid in fig. 15). In the unlocked position, the toggle lock member 7112 allows the band 7014 to move freely through the central aperture 7108 relative to the tension bar 7084. In the locked position, the clamping portion 7116 of the toggle lock member 7112 clamps the band 7014 against the head 7106 to limit or prevent the first end 7022 of the band 7014 from moving relative to the tension bar 7084.

The adjustment 7086 may include a grip wheel 7118 and a neck 7120. A central aperture 7122 extends through the grip wheel 7118 and the neck 7120. At least a portion of the central aperture 7122 extending through the grasping wheel 7118 is threaded and threadably engages the threaded shaft 7104 of the tensioning rod 7084. The neck 7120 is received into a groove 7098 of the main body 7082 and can include a plurality of resiliently flexible arms 7124 having barbed ends 7126, the barbed ends 7126 snap into engagement with the main body 7082. In this manner, the adjustment member 7086 is axially fixed to the main body 7082 and is rotatable relative to the main body 7082. Thus, rotation of the adjustment member 7086 relative to the main body 7082 causes corresponding axial movement of the tensioning rod 7084 relative to the main body 7082 between a first position (shown in fig. 14 and 15) and a second position (shown in fig. 19 and 20).

The release sleeve 7088 may be a generally tubular body that includes a pair of flanges 7128 that extend radially outward. The central aperture 7130 may extend axially through the release sleeve 7088. The shaft portion 7095 of the main body 7082 may be movably received into the central aperture 7130. The release sleeve 7088 may also include a pair of radially extending apertures 7132 in communication with the central aperture 7130. The protrusion 7134 (fig. 14) extending radially outward from the shaft portion 7095 of the main body 7082 may releasably engage the radially extending aperture 7132 to releasably retain the release sleeve 7088 in a first position (shown in fig. 14, 15, 19, and 20) relative to the main body 7082. Applying a sufficiently strong axially upward force on the release sleeve 7088 relative to the main body 7082 can cause the protrusions 7134 to no longer engage the apertures 7132 and allow the release sleeve 7088 to move axially upward relative to the main body 7082 to a second position (shown in fig. 21 and 22).

The retaining collar 7090 may include a generally tubular body 7136 and a pair of retaining arms 7138 extending axially downward from the tubular body 7136. The tubular body 7136 may include a central aperture 7135 extending axially therethrough. The tubular body 7136 can also include a plurality of flexible barbed arms 7140 that snap into engagement with an annular groove 7142 formed in the shaft portion 7095 of the main body 7082. The retaining arms 7138 may be resiliently flexible relative to the tubular body 7136. As shown in fig. 18, the radially inwardly extending tabs 7144 of the retaining arms 7138 may releasably engage the locking device 7017 to releasably secure the tensioning device 7018 thereto.

As shown in fig. 13, the finishing member 7092 may be a generally cylindrical member that includes a first groove 7146 formed in the first end 7148 and a second groove 7150 formed in the second end 7152 (fig. 14 and 15). The distal end 7154 of the shaft portion 7095 of the main body 7082 may be received into the first recess 7146. Barbed fingers 7156 (fig. 13) formed on the first end 7148 may fixedly engage one or more slots or apertures 7158 (fig. 14 and 15) via a snap-fit.

When the retaining collar 7090 is engaged with the locking device 7017, the locking device 7017 can be received into the second recess 7150 (as shown in fig. 14, 15, 18, and 22). The second end 7152 can include a slot 7160 through which the tab 7076 of the cam member 7052 can extend when the cam member 7052 is in the unlocked position (as shown in fig. 18). When the main body 7082 is rotated relative to the locking device 7017 in the direction indicated by arrow a1 in fig. 20 (which causes the trim member 7092 to rotate with the main body 7082), the surfaces 7163 (best shown in fig. 18) defining the slots 7160 push the tabs 7076, thereby rotating the cam member 7052 to the locked position.

A bow-tie shaped aperture 7162 (fig. 16) may be formed through the wall 7164 separating the first recess 7146 and the second recess 7150. The aperture 7162 may include first and second relatively

wide end portions

7166, 7168 and a relatively narrow central portion 7170 disposed between the

end portions

7166, 7168. It will be understood that in some embodiments, the aperture 7162 may alternatively be shaped. When the retaining collar 7090 is engaged with the locking device 7017, the aperture 7162 is aligned with the aperture 7070 of the locking device 7017 such that the strap 7014 can pass through the aperture 7162 and extend into the central aperture 7094 of the main body 7082 (as shown in fig. 14 and 15). In some embodiments, one or more blades (not shown) may extend radially into the central portion 7170 of the aperture 7162. As the main body 7082 is rotated relative to the locking device 7017 (which causes the finishing member 7092 to rotate with the main body 7082), one or more surfaces defining the orifice 7162 may cut or shear the band 7014 to the length shown in fig. 21 and 23.

With continued reference to fig. 11-24, the operation of the closed loop system 7000 will be described in detail. As described above, the stent 7016 and the locking device 7017 may cooperate to tighten the band 7014 around the

portions

12a, 12b of the patient's bone 12. The tensioning device 7018 may tighten the strap 7014 around the bone 12 and trim away the excess length of the strap 7014.

As shown in fig. 11, a needle 7020 may be attached to the first end 7022 of the band 7014 to assist the surgeon in passing the first end 7022 of the band 7014 through tissue surrounding the bone 12. Thereafter, the surgeon removes the needle 7020. With the cam member 7052 in the unlocked position, the first end 7022 of the band 7014 can pass through the

apertures

7058, 7034, 7070 of the locking device 7017. Thereafter, with the tensioning device 7018 attached to the locking device 7017 (as shown in fig. 11), the first end 7022 of the strap 7014 can be passed upwardly through the aperture 7162 in the trim member 7092, into the central aperture 7094 of the main body 7082, through the central aperture 7108 of the tensioning rod 7084, as shown in fig. 14 and 15.

With the first end 7022 of the band 7014 extending through the head 7106 of the tension rod 7084, the toggle lock member 7112 may be moved from an unlocked position (shown in phantom in fig. 15) to a locked position (shown in solid in fig. 15) to clamp the first end 7022 of the band 7014 in place and restrict movement of the first end 7022 of the band 7014 relative to the tension rod 7084.

With the toggle lock member 7112 in the locked position, the surgeon may grasp the grip portion 7093 of the main body 7082 with one hand and may grasp the grasping wheel 7118 of the adjustment piece 7086 with the other hand and rotate the adjustment piece 7086 relative to the main body 7082 in the direction a2 (fig. 19), while keeping the main body 7082 fixed relative to the locking device 7017. As described above, this rotation of the adjustment member 7086 relative to the main body 7082 causes the tensioning rod 7084 to move axially (i.e., in a direction along the longitudinal axis of the tensioning rod 7084) upward relative to the adjustment member 7086, the main body 7082, and the locking device 7017, as shown in fig. 19. As described above, the engagement between the anti-rotation pin 7102 and the slot 7105 prevents relative rotation between the tension rod 7084 and the main body 7082 while the adjustment member 7086 rotates relative to the main body 7082. Upward axial movement of the tension rod 7084 relative to the main body 7082 with the first end 7022 of the band 7014 clamped in place with the toggle lock member 7112 moves the first end 7022 upward relative to the locking device 7017, thereby tightening the band 7014 about the patient's bone 12 (i.e., the circumference of the encircled portion 7172 (fig. 19) of the band 7014) is reduced). Rotation of the adjustment member 7086 relative to the main body 7082 in a direction opposite to the direction a2 causes the tensioning rod 7084 to move axially downward relative to the adjustment member 7086, the main body 7082, and the locking device 7017, thereby slackening the wrapped portion 7172 of the band 7014.

Once the surgeon has rotated the adjustment member 7086 to achieve the desired tension in the band 7014, the surgeon may grasp the release sleeve 7088 with one hand and grasp the grasping portion 7093 of the main body 7082 with the other hand and rotate the main body 7082 relative to the locking device 7017, the release sleeve 7088, and the retaining collar 7090 in the direction a1 as shown in fig. 20. As described above, rotating the main body 7082 in the direction a1 causes the trim member 7092 to rotate in the direction a1 relative to the locking device 7017, which causes the surface 7163 of the slot 7160 to urge the tab 7076 of the cam member 7052 to the locked position (fig. 23). As described above, when the cam member 7052 is in the locked position, the cam member 7052 clamps the band 7014 relative to the second housing piece 7050 of the locking device 7017 to limit or prevent relative movement of the band 7014 relative to the locking device 7017. In some embodiments, the cam member 7052 can be moved from the unlocked position to the locked position by rotating the main body 7082 approximately ninety degrees relative to the locking device 7017. It will be appreciated that in some embodiments, more or less than 90 degrees of rotation of the main body 7082 may be required to move the cam member 7052 from the unlocked position to the locked position.

After the cam member 7052 is moved to the locked position, the surgeon may continue to rotate the main body 7082 relative to the locking device 7017, the release sleeve 7088, and the retention ferrule 7090 in the direction a1 to trim the band 7014 at a position that is substantially flush with the upper surface 7174 of the second housing member 7050 of the locking device 7017 (as shown in fig. 23 and 24) or at a position between the upper surface 7174 and the distal end 7154 of the main body 7082. This continued rotation of the main body 7082 and the finishing member 7092 relative to the locking device 7017 causes the surface defining the aperture 7162 of the finishing member 7092 to cut or shear the band 7014. In some embodiments, after the cam member 7052 is rotated to the locked position, the band 7014 can be cut by the trimming member 7092 within two full rotations (720 degrees) of the main body 7082. It will be appreciated that in some embodiments, more or less than 720 degrees of rotation of the main body 7082 and the trimming member 7092 may be required to trim the band 7014.

After the band 7014 has been trimmed, the surgeon may slide the release sleeve 7088 axially upward relative to the main body 7082, as shown in fig. 21 and 22. With the release sleeve 7088 in this upward position, the retaining arms 7138 are free to flex laterally outward away from the locking device 7017 to enable the retaining arms 7138 to disengage from the locking device 7017, thereby enabling the tensioning device 7018 to disengage from the locking device 7017, as shown in fig. 21. After removing the tensioning device 7018 from the locking device 7017, the tensioning device 7018 may be discarded (i.e., placed in a waste container) or sterilized and reused with a different strap 7014 and locking device 7017.

A threaded fastener (not shown) may be driven through the aperture 7046 of the stent 7016 into the patient's bone 12 to further secure the stent 7016 relative to the bone 12. This may be done, for example, after the tensioning device 7018 is disengaged from the locking device 7017 or at any time after the band 7014 is tightened about the bone 12. The band 7014, locking device 7017, stent 7016, and threaded fastener are made of implantable materials and can be left in the patient after the surgical procedure is completed. Once the patient's bone 12 heals, the band 7014, locking device 7017, stent 7016, and threaded fasteners may be removed from the patient's body in a subsequent surgical procedure.

Referring to fig. 25-28, another locking device 8017 and strap 8014 are provided that can be incorporated into a closed loop system 7000, rather than a locking device 7017 and strap 7014. The structure and function of the locking device 8017 and strap 8014 are similar or identical to the structure and function of the locking device 7017 and strap 7014 described above, with the exceptions noted herein and/or shown in the figures. Therefore, similar features will not be described in detail.

The locking device 8017 may include a housing 8050 and a cam member 8052. The housing 8050 can be a one-piece unitary body having a first cavity 8054 (fig. 26), a second cavity 8056, and an elongated orifice 8058. A first end 8024 of the band 8014 may be received in the first cavity 8054. A pin 8055 or other fastener can be received into the aperture 8057 of the housing and the aperture 8036 in the first end 8024 of the band 8014 to securely connect the first end 8024 to the housing 8052 (it will be understood that the first end 8024 of the band 8014 can not include an aperture similar to the aperture 7034 of the band 7014 or a tab similar to the tab 7026 of the band 7014).

The cam member 8052 can be received within the second cavity 8056 and can rotate relative to the housing 8050 between an unlocked position (fig. 25 and 26) and a locked position (fig. 27 and 28). The cam member 8052 can be similar or identical to the cam member 7052, except that the cam member 8052 can include a deflectable tab 8060 extending outwardly therefrom. The tab 8060 can include a barbed tip 8062 that releasably engages a first aperture 8064 in the housing 8050 in the unlocked position and a second aperture 8066 in the housing 8050 in the locked position. The first aperture 8064 and the second aperture 8066 can be holes, notches, grooves, slots, or another other opening. A pin 8068 or other fastener can extend through an aperture 8070 in the housing 8050 and an aperture 8072 in the cam member 8052 to rotatably attach the cam member 8052 to the housing 8050. The tabs 7144 (fig. 18) of the retention ferrule 7090 can engage the grooves 8074 formed in the housing member 8050 to releasably secure the locking device 8017 to the tensioning device 7018. Although not shown in fig. 27 and 28, in the locked position, the cam member 8052 can clamp a portion (not shown) of the band 8014 within the elongate aperture 8058 of the housing 8050, thereby securing the band 8014 relative to the housing 8050 in the same manner as described above in connection with the locking device 7017 and the band 7014.

The foregoing description of the embodiments has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosure. Individual elements or features of a particular embodiment are generally not limited to that particular embodiment, but, where applicable, are interchangeable and can be used in a selected embodiment, even if not specifically shown or described. The individual elements or features of a particular embodiment may be varied in a number of ways. Such variations are not to be regarded as a departure from the disclosure, and all such modifications are intended to be included within the scope of the disclosure.

Claims

1. A closure system for securing a first bone portion to a second bone portion, the closure system comprising:

a band adapted to encircle the first and second bone portions;

a locking terminal fixedly engaging a first portion of the strap and selectively fixedly engaging a second portion of the strap; and

a tensioning device including a body and a threaded rod received into the body and engaging the band such that movement of the threaded rod in an axial direction relative to the body moves the second portion of the band in an axial direction relative to the first portion of the band, the tensioning device further including:

a sleeve slidably receiving the body; and

a locking arm extending from the body and configured to releasably secure the tensioning device relative to the strap.

2. The closure system of claim 1, wherein the tensioning device comprises a resiliently flexible ferrule received in the sleeve and receiving a portion of the body.

3. The closure system of claim 2, wherein the ferrule includes a first axial end that engages an annular groove in the body and a second axial end that removably engages the locking terminal.

4. The closure system of claim 3, wherein the sleeve is axially movable relative to the body and the collar between a first position that limits radial flexure of the collar and a second position that allows the collar to flex radially outward relative to the body.

5. The closure system of claim 1, wherein the tensioning device comprises an adjustment member partially received into the body and threadingly engaging the threaded rod, the adjustment member being rotatable relative to the body and axially fixed relative to the body such that rotation of the adjustment member relative to the body causes corresponding axial movement of the threaded rod relative to the body.

6. The closure system of claim 5, wherein the tensioning device comprises an anti-rotation pin extending through the body and engaging the threaded rod to limit relative rotation between the threaded rod and the body while allowing relative axial movement between the threaded rod and the body.

7. The closure system of claim 1, wherein the tensioning device comprises a toggle lock mounted to the threaded rod and movable relative to the threaded rod between an unlocked position allowing the band to move through an aperture in the threaded rod and a locked position in which the toggle lock engages the band and restricts movement of the band relative to the threaded rod.

8. The closure system of claim 1, wherein the locking terminal comprises a housing and a cam member, the housing engaging a first portion of the band, the cam member rotatable relative to the housing and the first portion of the band between an unlocked position allowing movement of a second portion of the band through the housing and a locked position in which the cam member engages the second portion of the band to limit movement of the second portion relative to the housing and the first portion.

9. The closure system of claim 8, wherein the housing comprises first and second housing members, the first portion of the band and the cam member being disposed between the first and second housing members.

10. The closure system of claim 9, wherein the first and second housing pieces and the first portion of the band each include apertures that align with one another to allow the second portion of the band to pass therethrough.

11. The closure system of claim 8, wherein the housing is a one-piece unitary body.

12. The closure system of claim 8, wherein in the locked position, the cam member clamps the second portion of the band against the housing.

13. The closure system of claim 8, wherein the first portion of the band includes a deflectable tab that allows movement of the cam member from the unlocked position to the locked position and restricts movement of the cam member from the locked position to the unlocked position.

14. The closure system of claim 8, wherein the cam member includes a deflectable tab that releasably engages the housing in the locked position to limit movement of the cam member out of the locked position.

15. The closure system of claim 14, wherein the deflectable tab releasably engages a first aperture in the housing member in the locked position to limit movement of the cam member out of the locked position, and wherein the deflectable tab releasably engages a second aperture in the housing in the unlocked position to limit movement of the cam member out of the unlocked position.

16. The closure system of claim 8, wherein the body includes a member secured to an axial end of the body, the member including a rim defining a central recess receiving the locking terminal, the rim including a keyway receiving a portion of the cam member such that relative rotation of the body with respect to the locking terminal causes the cam member to rotate from the unlocked position to the locked position.

17. The closure system of claim 16, wherein the member comprises a shear aperture through which the second portion of the band extends, and wherein a wall of the shear aperture is configured to sever the second portion of the band in response to rotation of the body relative to the locking terminal.

18. The closure system of claim 17, wherein the shear aperture is configured such that a wall of the shear aperture will only sever the second portion of the band after the body has been rotated at least ninety degrees relative to the locking terminal.

19. The closure system of claim 17, wherein the shear orifice is a bow-tie shaped orifice.

20. The closure system of claim 1, wherein a sleeve is molded around the band and through at least one aperture in the band.

21. A tensioning device for tightening a band about a first bone portion and a second bone portion, the tensioning device comprising:

an elongated body including a central aperture extending axially through the body;

a threaded rod received into the central aperture of the body and adapted to engage the band such that movement of the threaded rod in an axial direction relative to the body moves the second portion of the band in an axial direction relative to the first portion of the band;

a sleeve slidably receiving the body; and

a resiliently flexible locking arm extending from the body and configured to releasably secure the tensioning device relative to the strap.

22. The tensioning device of claim 21, wherein the locking arm is part of a collar received into the sleeve and receiving a portion of the body.

23. The tensioning device of claim 22, wherein the collar includes an axial end that engages an annular groove in the body.

24. The tensioning device of claim 21, wherein the sleeve is axially movable relative to the body and the locking arm between a first position that limits radial flexing of the locking arm and a second position that allows the locking arm to flex radially outward relative to the body.

25. The tensioning device of claim 21, further comprising an adjustment member partially received in the body and threadingly engaging the threaded rod, the adjustment member being rotatable relative to the body and axially fixed relative to the body such that rotation of the adjustment member relative to the body causes corresponding axial movement of the threaded rod relative to the body.

26. The tensioning device of claim 25, further comprising an anti-rotation pin extending through the body and engaging the threaded rod to limit relative rotation between the threaded rod and the body while allowing relative axial movement between the threaded rod and the body.

27. The tensioning device of claim 21, further comprising a toggle lock mounted to the threaded rod and movable relative to the threaded rod between an unlocked position allowing the band to move through an aperture in the threaded rod and a locked position in which the toggle lock engages the band and limits movement of the band relative to the threaded rod.

28. The tensioner of claim 21, wherein the body comprises a shear secured to an axial end of the body, the shear comprising a rim defining a central groove and a keyway extending through the rim.

29. The tensioning device of claim 28, wherein the shear includes a shear aperture extending from a central groove of the shear to a central aperture of the body.

30. The tensioning device of claim 29, wherein the shear orifice is a bow tie shaped orifice.

31. A closure system comprising the tensioning device of claim 29, and further comprising a locking terminal having a housing and a cam member, the housing engaging a first portion of the band, the cam member rotatable relative to the housing and the first portion of the band between an unlocked position allowing movement of a second portion of the band through the housing and a locked position in which the cam member engages the second portion of the band to restrict movement of the second portion through the housing.

32. The closure system of claim 31, wherein the housing comprises first and second housing members, the first portion of the band and the cam member being disposed between the first and second housing members.

33. The closure system of claim 32, wherein the first and second housing pieces and the first portion of the band each include apertures that align with one another to allow the second portion of the band to pass therethrough.

34. The closure system of claim 31, wherein the housing is a one-piece unitary body.

35. The closure system of claim 31, wherein in the locked position, the cam member clamps the second portion of the band against the housing.

36. The closure system of claim 35, wherein the first portion of the band includes a deflectable tab that allows movement of the cam member from the unlocked position to the locked position and restricts movement of the cam member from the locked position to the unlocked position.

37. The closure system of claim 35, wherein the cam member includes a deflectable tab that releasably engages the housing in the locked position to limit movement of the cam member out of the locked position.

38. The closure system of claim 37, wherein the deflectable tab releasably engages a first aperture in the casing member in the locked position to limit movement of the cam member out of the locked position, and wherein the deflectable tab releasably engages a second aperture in the casing in the unlocked position to limit movement of the cam member out of the unlocked position.

39. The closure system of claim 35, wherein the central groove of the shear member receives the locking terminal, and wherein the keyway of the shear member receives a portion of the cam member such that relative rotation of the body with respect to the locking terminal causes the cam member to rotate from the unlocked position to the locked position.

40. The closure system of claim 39, wherein a second portion of the band extends through the shear aperture, and wherein a wall of the shear aperture is configured to sever the second portion of the band in response to rotation of the body relative to the locking terminal.

41. The closure system of claim 40, wherein the shear aperture is configured such that a wall of the shear aperture severs the second portion of the band only after the body is rotated at least ninety degrees relative to the locking terminal.

42. The closure system of claim 31, wherein a sleeve is molded around the band and through at least one aperture in the band.